Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury Spinal Cord Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-31

Study Completion Date

2022-01-31

Brief Summary

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The purpose of this study is to analyze the safety and efficacy of autologous bone marrow mesenchymal stem cell transplantation in patients with thoracolumbar chronic and complete spinal cord injury.

Detailed Description

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This is a randomized, non-placebo controlled, prospective, phase II clinical trial. The study population will consist of 40 patients who had spinal cord injury for at least 12 months, with thoracolumbar chronic and complete spinal cord injury, ASIA grade A.

A practitioner, a surgeon and a nurse will review the medical records of the patients to determine the presence / absence of inclusion / exclusion criteria. If the patient is a potential candidate for the study, an interview will be scheduled to review and confirm his/her eligibility. Patients will undergo a series of clinical and neurological assessments and will also be submitted to the following procedures:

* Cell blood count;
* Biochemical analysis (measurement of electrolytes - sodium, potassium, magnesium);
* Renal function tests (urea and creatinine);
* Liver function tests;
* Coagulation profile;
* Metabolic profile (glucose, total cholesterol and fractions);
* Urine summary and culture;
* Serology required for blood transfusion and marrow transplant in Brazil;
* Electrocardiogram;
* Chest X-Ray;
* Bone densitometry;
* Urodynamic studies;
* Somatosensory evoked potential;
* Computed tomography of thoracic and lumbar spine;
* Magnetic resonance imaging of the thoracic and lumbar spine.

Also as part of the preoperative evaluation, the patients will respond to questions from the SF (Short Form) -36 questionnaire (for assessment of quality of life) and the questionnaires for the assessment of neuropathic pain. Clinical follow-up will be kept for patients who suspend their participation in the study for any adverse event and / or laboratory abnormality, or for the patient's own desire, following insurance protocols. In addition to the clinical and surgical follow-up, specific medical care will be offered to patients who experience adverse events, until stabilization of the patient, even if the target date for completion of the study has been exceeded. The candidates included in the study will be asked to voluntarily participate and give their informed written consent.

Conditions

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Spinal Cord Injury

Keywords

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Spinal cord injury Paraplegia Stem cells Mesenchymal cells

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treated group

Twenty subjects will be randomly assigned to receive two percutaneous injections of mesenchymal stem cells, with a 3-month interval between the injections.

Group Type EXPERIMENTAL

Autologous mesenchymal cells transplantation

Intervention Type BIOLOGICAL

Two percutaneous injections of mesenchymal stem cells, with a 3-month interval between the injections.

Control group

Twenty subjects will be randomly assigned to be clinically followed, without any specific intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Autologous mesenchymal cells transplantation

Two percutaneous injections of mesenchymal stem cells, with a 3-month interval between the injections.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Blunt spinal cord injury at thoracolumbar level, between T1 and L2, or penetrating spinal cord injury, at the same level, provided that the mechanism of injury had been spinal shock, ischemia or hematoma, with at least 12 months of injury;
* ASIA grade A;
* Signing of the written consent.

Exclusion Criteria

* Spinal cord injuries by sharp objects, firearms, and not traumatic or congenital causes, even if at different levels of the spinal cord;
* Concomitant brain injuries;
* Diabetes mellitus type 1 or 2 as defined by fasting glucose above 126 mg / use of medication and medical history;
* Infectious processes in acute and / or chronic course, confirmed by additional tests and / or medical history;
* Immunodeficiency, autoimmune diseases and neoplastic processes, confirmed by additional tests and / or medical history;
* Terminal, neurodegenerative, primary hematologic and musculoskeletal diseases confirmed by additional tests and / or past medical history;
* Osteopathies reflecting increased risk for bone marrow puncture;
* Coagulopathies;
* Severe organ failure (heart, kidney or liver), confirmed by additional tests or medical history;
* Pregnancy or lactation;
* Clinical complications that hinder or contraindicate the surgical procedure;
* Use of metallic implants near vascular structures (such as cardiac pacemaker), or other contraindication to magnetic resonance imaging;
* Psychiatric disorders, psychosocial and cognitive impairment confirmed by medical evaluation;
* Abusive use of alcohol and / or illegal substances use;
* Participation in other clinical trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Ricardo Ribeiro dos Santos

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

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Ricardo Ribeiro-dos-Santos, PhD

Role: CONTACT

Phone: +557132816455

Email: [email protected]

Other Identifiers

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SCI-005

Identifier Type: -

Identifier Source: org_study_id

Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury Spinal Cord Injury

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Treated group

Autologous mesenchymal cells transplantation

Control group

Interventions

Autologous mesenchymal cells transplantation

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Hospital Sao Rafael

Responsible Party

Ricardo Ribeiro dos Santos

Principal Investigators

Ricardo Ribeiro-dos-Santos, PhD

Milena BP Soares, PhD

Bruno SF Souza, MD, Msc

Ticiana F Larocca, MD, Msc

Rodrigo L Alves, MD, PhD

Carolina T Macedo, MD, MSc

André C Matos, MD

Cristiane F Villarreal, PhD

Antônio Olímpio S Moura, MD

Eduardo Brazão, MD

Kátia N Silva, MSc

Daniela N Silva, MSc

Clarissa LM de Souza, MD

Central Contacts

Ricardo Ribeiro-dos-Santos, PhD

Other Identifiers

SCI-005